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"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"

NCT06556836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2026-04-09

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effectiveness of ultrasound for locating epidural catheters compared to the gold standard, epidurography. This study is focused on patients undergoing major open abdominal surgeries, who often experience moderate to severe pain during the first 24 to 48 hours after surgery.

The main questions it aims to answer are:

How does the accuracy of ultrasound for detecting epidural catheter placement compare to that of epidurography? Can ultrasound provide a reliable alternative to epidurography in surgical settings where epidurography is not feasible?

In this trial, participants will:

Undergo a standard epidural analgesia procedure for pain management during their surgery.

Have their epidural catheter placement checked using both ultrasound and epidurography.

Report their pain levels and any issues with pain control during the immediate postoperative period.

The study will assess whether ultrasound can effectively replace epidurography in confirming catheter placement, potentially offering a less invasive and more practical solution in routine surgical environments.

Conditions

  • Open Abdominal Surgery
  • Epidural Analgesia

Interventions

DEVICE

Doppler color and M-Mode ultrasound

A diagnostic test intervention using color Doppler and M-Mode ultrasound will be conducted to localize the catheter within the epidural space and compared with epidurography.

DEVICE

Epidurography

An epidurography is an imaging procedure used to visualize the epidural space of the spine. The process involves inserting an epidural catheter, through which a contrast dye is injected. Fluoroscopy or X-rays are then used to capture real-time images of the contrast flow, helping to ensure the catheter's correct placement and to detect any localization anomalies. In this study, the epidurography will be performed in the radiology department by a radiologist and a pain management interventionist.

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • ANA LILIA GARDUÑO-LOPEZ, M.Sc · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • GUSTAVO LUGO-GOYTIA, D.Sc · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-07-15
Completion
2025-08-30
FDA Device
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556836 on ClinicalTrials.gov